Notice of Participation of the National Center for Complementary and Integrative Health (NCCIH) in PA-18-876 "Advancing Mechanistic Probiotic/Prebiotic and Human Microbiome Research (R01 Clinical Trial Not Allowed)"

Issued by
National Center for Complementary and Integrative Health (NCCIH)

Purpose

Part 1. Overview Information

Components of Participating Organizations

National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Drug Abuse (NIDA)
Office of Dietary Supplements (ODS)

National Center for Complementary and Integrative Health (NCCIH)actively supports research to examine mechanisms of action for probiotics/prebiotics and microbiome as high research priorities. Particularly interested outcomes include prevention and symptom management of inflammatory and pain conditions, mild to moderate anxiety, depression, and sleep conditions, and behavioral research to promote healthier lifestyles [e.g., healthy eating, physical exercise]. NCCIH will accept applications focusing on probiotic (with or without prebiotic) studies, their interactions with other natural products, or the effects of mind-body modalities on microbes. NCCIH will not fund applications that include specific aims examining clinical efficacy/effectiveness.

Research approaches supported include mechanistic in vitro models and pre-clinical animal studies, as well as mechanistic clinical trials where applicable addressing the following problems:

Probiotic [with or without prebiotic] studies that can produce a meaningful change in measurable biological signatures (e.g., mechanism of action) in the genotype/phenotype of interest.

Probiotic [with or without prebiotic] studies that demonstrate mechanistic effects on essential functions [immunoregulatory; anti-inflammatory; signaling pathways; energy metabolism] that enhance health and justify selection of the modality proposed to be used in the study.

Probiotic [with or without prebiotic] studies utilizing multi-omic and cell-based technologies and ensure rigor and reproducibility, validation or optimization strategies on essential functions [e.g., dose-dependent or cumulative effects] that impact biological signatures and minimize the risk of toxicity and adverse events.

Probiotic [with or without prebiotic] studies that distinguish microbiome-genomic from host genomic expression, and their individual yield of metabolites, interactions, and impacts on human health [e.g., gut-brain; gut-hepatic; gut-bone axis].

Probiotic [with or without prebiotic] studies focused on distinguishing impacts of microbially produced and dietary-metabolites, including their impacts on essential functions across the life span [e.g., developmental biology; senescence].

Probiotic [with or without prebiotic] studies of lifestyle and behavior role on energy metabolism and health impacts.